Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-30 @ 3:14 AM
Study NCT ID:
NCT07194161
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy
Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Organization:
Study Overview
Official Title:
Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIRIT
Brief Summary:
The goal of this observational study is to describe the impact of recurrence on the quality of life of patients treated with radical surgery and laser therapy.
The secondary objective is to describe in patients treated with radical surgery and laser treatment :
* Intensity of pain and discomfort
* Duration of nursing care since surgery
* Duration of inactivity since intervention
The secondary objective is to describe in patients treated with radical surgery and laser treatment :
* Intensity of pain and discomfort
* Duration of nursing care since surgery
* Duration of inactivity since intervention
Detailed Description:
This is a single-centre exploratory study of patients previously treated for a pilonidal cyst who are consulting for a recurrence.
The study consists of a single assessment, the data from which will be recorded on an electronic case report form (CRF).
The objective of this study does not impose any particular constraints. The only evaluation of the study is carried out when the patient comes in for consultation for a recurrence of a pilonidal cyst.
Quality of life will be assessed using the The MOS 36-item short-form health survey (SF-36) scale and the Wound quality of life in Chronic Wounds survey (Wound QoL17).
Pain and discomfort will be assessed using a simple numerical scale ranging from 0 to 10.
The study consists of a single assessment, the data from which will be recorded on an electronic case report form (CRF).
The objective of this study does not impose any particular constraints. The only evaluation of the study is carried out when the patient comes in for consultation for a recurrence of a pilonidal cyst.
Quality of life will be assessed using the The MOS 36-item short-form health survey (SF-36) scale and the Wound quality of life in Chronic Wounds survey (Wound QoL17).
Pain and discomfort will be assessed using a simple numerical scale ranging from 0 to 10.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: